Smiths Medical ASD, Inc. 2024-10-30 Health serious FDA
Health · FDA · Recall #FDA-Z-0187-2025
medex Arterial Kit 1/EA, Product Code REF MX7827 Recall
Issued October 30, 2024 · Smiths Medical ASD, Inc.
In October 2024, Smiths Medical ASD, Inc. recalled the medex Arterial Kit 1/EA, Product Code REF MX7827, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
What you should do
- 1 Stop using medex Arterial Kit 1/EA, Product Code REF MX7827 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smiths Medical ASD, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Smiths Medical ASD, Inc.
- Category
- Health
- Recall date
- October 30, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-0187-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Smiths Medical ASD, Inc. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.